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**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
Position Summary:
Manager Clinical Operations is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Manager Clinical Operations supports TA Director and Country Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.
This individual is responsible for line management of Site Managers (SM) and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/Global Development (GD) overall.
Principal Responsibilities:
Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.
Accountable for the acquisition of new talents and development of human resources. 5 Guide direct reports in issue resolution and communication with involved stakeholders.
Lead organizational changes and effectively communicate on priority shifts as required.
Review and approve expenses in compliance with the company policies.
Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives.
Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
Define, execute or support of long term strategy in alignment with GCO, GD and JJIM R&D strategies to position the local and global GCO organization for success.
Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.
Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
Review operational and quality metrics regularly and drive follow-up actions as appropriate.
Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/GD overall. Foster a culture of continuous improvement and innovation within the local GCO team.
Model Credo based culture within the local GCO team.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Principal Relationships:
Primary Reporting Structure: Reports to Director Clinical Operations
Primary interfaces: LTMs, SMs, CTAs, Country Head, other Functional Managers (FM)/Clinical Research Managers (CRM), Program Delivery Leaders (PDL)/Trial Delivery Leaders (TDL), Strategic Account Leads (SAL) and supporting roles in the country.
Other Internal Interfaces: R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Delivery Units (DU), Integration and Process Optimization, Integrated Data Analytics & Reporting (IDAR), BRQC, HCC, External Alliances, Contracts & Centralized Services (CCS) and others as required.
External Interfaces: Functional management of relevant vendors, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required.
Education and Experience Requirements:
▪ Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
▪ Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
▪ Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
▪ Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.
▪ Experience in mentoring/coaching (line management experience desirable). Proficient in decision-making and financial management.
▪ Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision. ▪ Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
＜For Internal Applicants＞
- Based on your experience and interview evaluation, the position title and level may vary.
- If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
- For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.
**Required Skills: **
Preferred Skills:
Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making, Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements, Program Management, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management